Angiograms are patency "shadow grams" they can't tell you what process lead to a vessel failure just that it is open, partially closed or closed. No explants or histology so nobody knows where or how the mesh veins fail. Does it fail proximally, distally somewhere in between? Is it intimal hyperplasia, thrombus, soft plaque, mixed disease, inflammation, etc? So new implantation technique is speculation. The data will tell for sure.
"not knowing why or how the mesh fails".....I do not understand this comment at all. Angios are the golden rule to provide the data. other imaging is also available. they know where the problems were. please explain??
"no multicenter data shows the mesh outperforming the controls"...yes, based on the old technique I agree. What about the new implantation technique which removed the problem areas causing failure?
Not knowing why or how the mesh fails makes it hard to formulate a solution. No multicenter data shows the mesh outperforming the controls. 5 yrs is a long time to wait for data. I doubt this msg board will be here 2020...
Sentiment: Strong Sell
a clown, who's only source of employment for the past several years consists of posting lies and fud on lonely forgotten yahoo message boards , dismisses the professional accomplishments of serial entrepreneur Villafaña.
Does it get any more unintentionally ironic than that ? avi thanks for the chuckle, you aren't worth a whole laugh. Now that i have your money anyway ;0 !
this article explains why KIPS changed to the new implant technique. article is old news. new implant technique results out soon. enough patients have enrolled. waiting results.
please define failure mode? The real value in this Mesh device is the 5 year angio patency. the current CABG method using saphenous with no external support produces poor patency. Mesh provides much improved patency at 5 years.
Except that; = 4mm grafts are rare, 83% patency is not better than published randomized, multi-center vein graft results, and the failure mode of the mesh is unknown.
Sentiment: Strong Sell
heads up..... Aegis Capital Corp. handling the latest KIPS offering? hmmmmmmmm
You mupps remember GunnAllen Financial? When FINRA shut GunnAllen down I believe as many as 70 brokers shifted to Aegis Capital Corp. Head's up. Do your DD.
You might find this of interest. It's from the UAMY message board: " "On March 13, 2014, the Company issued Herbert Denton, the Company investor relations consultant, 25,000 shares of the Company’s common stock in exchange for a notes receivable of $30,000. Mr. Denton’s note bears interest of six percent and is due in monthly payments of $2,000.""
thanks "The 4 mm mesh had a significantly higher patency rate at 12 months (83.33%) " is what the subtle message has been, verifies the new procedures
Yes, the device has not shown any advantage over current techniques using unsupported vein grafts. Published results continue to disappoint... See the abstract from an Italian Heart Centre.
Saphenous Vein Graft Wrapping by Nitinol Mesh: A Word of Caution.
Rescigno G1, Aratari C1, Matteucci SM1, Parisi R2, Gironi G1, Schicchi N3, D'Alfonso A1, Cola V4, Torracca
Background Saphenous vein conduits are still used in a large proportion of coronary artery bypass graft (CABG) operations. A recently commercialized nitinol mesh seems to improve venous graft patency. The aim of this study was to control nitinol mesh vein graft patency in a series of isolated CABG patients by computed tomographic (CT) scan. Methods In 25 patients (mean age: 61.0 ± 9.65 years), operated for isolated CABG, the eSVS nitinol mesh (Kips Bay Medical Inc., Minneapolis, Minnesota, United States) was used to wrap one vein graft in each patient. Nitinol mesh vein graft was used to revascularize the right coronary (4 patients; 16%), the posterior descending (18 patients; 72%), and the obtuse marginal (3 patients; 12%) arteries. CT scans were performed at 1, 6, and 12 months postoperatively. Results The procedure was uneventful in all patients. CT controls showed an overall patency rate of 86.9, 42.7, and 34.1% at 1, 6, and 12 months, respectively. The 4 mm mesh had a significantly higher patency rate at 12 months (83.33%) than the 3.5 mm one which showed quite unsatisfactory results (20%) (p = 0.02). Patients with graft occlusion underwent stress testing which was mildly positive in two cases. One of them underwent a percutaneous revascularization. Conclusion Despite promising early results, use of nitinol mesh for saphenous veins was disappointing in our experience. Further refinements are probably needed.
He's a paid troll, his advice and warnings have made me thousands BY IGNORING IT ALL.
Best thing you could do for your fellow man is flag this as whole off FOR ABUSE.
A red thumb is pretty much like punching his timecard.
AV.i please come back to pozn, I seem to have sold all my shares for a quick 10% now I need more, please moron, help us out
" We have only completed one prospective, randomized, human clinical trial of 90 patients for our eSVS Mesh, which was conducted outside of the United States. The safety data from this trial has indicated that our eSVS Mesh and implant procedure do not result in an increase in patient complications during or in the 30 days after surgery. However, the effectiveness data from the trial is inconclusive primarily due to two complicating factors. First, one of the centers participating in the trial used implant methods incompatible with our eSVS Mesh. Second, the amount of reduction in the diameter of the saphenous vein grafts, or downsizing, prescribed in our instructions for use and sizing tool was too aggressive, resulting in a higher than anticipated closure rate in saphenous vein grafts, or SVGs, utilizing our eSVS Mesh, particularly when our smallest device, 3.0 millimeters, was used. As a result, based on angiographic studies nine to 12 months following surgery, 49% (36 of 73) of the eSVS Mesh vessels were patent, or open, and 81% (59 of 73) of the untreated vessels were patent.
No assurance can be provided that our current feasibility trial or our anticipated larger pivotal trial will be successful, or that once these studies are concluded, we will ever receive U.S. marketing approval for our eSVS Mesh. Due to our concern that the results of our feasibility trial prior to the change in the implant technique would not be adequate to allow us to obtain an IDE to perform a pivotal study and based upon our discussions with the FDA, we believe the success of the feasibility trial is entirely dependent upon the performance of our eSVS Mesh in the new technique patients. If we are unable to demonstrate with human clinical data that our eSVS Mesh is safe and improves the long-term patency of saphenous vein grafts as compared to traditional CABG surgery, we may be unable to obtain regulatory approval for, or successfully commercialize, our eSVS Mesh in the United State
As of March 1, 2015, Kips Bay has reached its targeted goal of enrolling 45-50 patients, treated with its new surgical technique, in the eMESH I clinical feasibility trial. Currently 105 patients have been enrolled in the feasibility trial, including 49 patients enrolled with the new implant technique.
Manny Villafaña, Chairman and Chief Executive Officer, commented "I am grateful for the support of our clinical investigators and the dedication of the Kips Bay team in driving us to this milestone in our feasibility trial." Mr. Villafaña continued, "We are now excited to focus our efforts on securing our follow-up angiograms by late third quarter or early fourth quarter of this year."
The eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts to strengthen SVGs used in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, the Company hopes to reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. To strengthen an SVG, the eSVS Mesh is manufactured from nitinol wire which gives the eSVS Mesh considerable strength, while remaining highly flexible and kink-resistant. Kips Bay is currently conducting a feasibility trial for the FDA, the objective of which is to demonstrate the initial safety and performance of the eSVS Mesh. Kips Bay expects to use the data from this study as the basis for the filing of a request for an investigational device exemption to perform a larger pivotal study which is required to demonstrate clinical effectiveness and support a request for approval to sell the eSVS Mesh in the United States
Read more at http://www.virtual-strategy.com/2015/03/12/kips-bay-medical-announces-achievement-enrollment-goal-and-provides-business-update-and-f?page=0,2#QO9GfIgHbk6HvDRA.99
No assurance can be provided that the Company's eMESH I clinical feasibility trial will be successful, that the FDA will approve an IDE for a pivotal study or that once these studies are concluded, the Company will receive U.S. marketing approval for the eSVS Mesh. If these events do not occur, Kips Bay may be forced to cease operations since the Company does not have any other products in development
Kips Bay Medical (OTC:KIPS) turned to founder, chairman & CEO Manny Villafaña and other backers for a private placement worth up to $3.25 million, as the company makes a last-ditch bid to get its eSVS surgical mesh on the market.
Manny’s Medical Alley
Manny gave us a brief overview of technologies he has been involved in, from the Chardack-Greatbatch pacemaker he sold for Medtronic to the St. Jude Medical heart valve he co-invented to today’s Kips Bay’s eSVS® Mesh that he believes will revolutionize coronary bypass surgery. Interestingly, his current company is named for the Kips Bay Boys Club in New York where he spent a lot of time as a kid and that he credits in part for his later success –
Mr. Villafana started his career with Medtronic, Inc. as the company's first international sales administrator. He went on to found Cardiac Pacemakers, Inc. (CPI), a CRM company that revolutionized the pacemaker industry by introducing a long-life lithium iodine pacemaker, a technology still utilized today by 100% of the market. CPI was ultimately acquired by Eli Lilly & Company, which spun out CPI as Guidant, which in turn was acquired in 2006 by Boston Scientific, Inc.
Mr. Villafana founded St. Jude Medical, Inc. in 1976. He led St. Jude Medical's development of a novel heart valve that still dominates the mechanical valve replacement market. He has also founded and led the public offering for medical technology companies such as GV Medical, Inc., ATS Medical, Inc. and CABG Medical, Inc. Every year, 250,000 Americans receive a lifesaving medical device developed by Mr. Villafana.
His current venture is developing a device for use in heart bypass surgery. The company is seeking to commercialize a mesh sheath, eSVS MESH, for use in coronary-artery bypass grafting, or CABG surgery. In CABG surgery, a vein is taken from a patient’s leg and attached to the heart to re-route blood from blocked arteries. The idea is to place a mesh sleeve over the vein graft and has been shown to increase the longevity of the graft.
"Kips Bay Medical has come a great distance in its short three and a half year history," Villafaña said in a statement issued by the company. "We have completed a 90 patient multi-national clinical trial which formed the basis for the eSVS MESH receiving the CE Mark, commercially launched the eSVS MESH in select international markets, and as of February 2011, completed an initial public offering of our common stock. We look forward to continuing our efforts to dramatically improve the success of CABG surgery worldwide.”
Sentiment: Strong Buy